drugset / Trial / NCT01598896

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

NCT01598896

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. People with schizophrenia are more likely than healthy people to abuse cannabis. Cannabis use may worsen clinical outcomes in this group, making the identification of pharmacotherapy to treat cannabis dependence in those with schizophrenia important. The investigators intend to test the combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist clonidine, for cannabis dependence in subjects with schizophrenia. The combination of dronabinol and clonidine may alleviate cannabis withdrawal symptoms while allowing treatment-seeking outpatients to benefit from medical management (MM) sessions when they are trying to stop using cannabis. The investigators propose to assess the relationship of dronabinol and clonidine, when added to MM, on cannabis use patterns in cannabis-dependent patients with schizophrenia. Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and clonidine will significantly reduce cannabis use compared to those receiving placebo.

Timeline

Start
2012-05
Primary completion
2017-08
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Clonidine Other / unclassified 0.1 mg
Subject Dronabinol Other / unclassified 5 mg

Indications